Martin Halle1,2, Martin Röhling3, Winfried Banzer4, Klaus Michael Braumann5, Kerstin Kempf6, David McCarthy7, Nina Schaller1, Hans Georg Predel8, Jürgen Scholze9, Dagmar Führer-Sakel10, Hermann Toplak11, Aloys Berg12. 1. Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany. 2. DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 3. West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany. martin.roehling@vkkd-kliniken.de. 4. Department of Sports Medicine, Institute for Sports and Sport Science, University of Frankfurt, Frankfurt, Germany. 5. Faculty of Psychology and Human Movement Sciences, Department of Sports and Movement Medicine, University of Hamburg, Hamburg, Germany. 6. West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany. 7. Public Health Nutrition Research Group, London Metropolitan University, London, UK. 8. Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany. 9. KARDIOS, Cardiologists in Berlin, Berlin, Germany. 10. Department of Endocrinology, Diabetes and Metabolism and Division of Laboratory Research, University Hospital Essen, University Duisburg-Essen, Essen, Germany. 11. Department of Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria. 12. Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Abstract
BACKGROUND: As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone. METHODS: In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters. RESULTS: From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks. CONCLUSIONS: A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.
RCT Entities:
BACKGROUND: As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone. METHODS: In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters. RESULTS: From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks. CONCLUSIONS: A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.
Authors: Kerstin Kempf; Martin Röhling; Winfried Banzer; Klaus Michael Braumann; Martin Halle; Nina Schaller; David McCarthy; Hans Georg Predel; Isabelle Schenkenberger; Susanne Tan; Hermann Toplak; Stephan Martin; Aloys Berg Journal: Nutrients Date: 2022-06-18 Impact factor: 6.706
Authors: Kerstin Kempf; Martin Röhling; Winfried Banzer; Klaus Michael Braumann; Martin Halle; David McCarthy; Hans Georg Predel; Isabelle Schenkenberger; Susanne Tan; Hermann Toplak; Aloys Berg; Stephan Martin Journal: Nutrients Date: 2021-04-23 Impact factor: 5.717
Authors: Martin Röhling; Andrea Stensitzky; Camila L P Oliveira; Andrea Beck; Klaus Michael Braumann; Martin Halle; Dagmar Führer-Sakel; Kerstin Kempf; David McCarthy; Hans Georg Predel; Isabelle Schenkenberger; Hermann Toplak; Aloys Berg Journal: Nutrients Date: 2021-01-26 Impact factor: 5.717
Authors: Martin Röhling; Kerstin Kempf; Winfried Banzer; Klaus Michael Braumann; Dagmar Führer-Sakel; Martin Halle; David McCarthy; Stephan Martin; Jürgen Scholze; Hermann Toplak; Aloys Berg; Hans-Georg Predel Journal: Nutrients Date: 2022-03-30 Impact factor: 5.717
Authors: Kerstin Kempf; Martin Röhling; Winfried Banzer; Klaus Michael Braumann; Martin Halle; Nina Schaller; David McCarthy; Hans Georg Predel; Isabelle Schenkenberger; Susanne Tan; Hermann Toplak; Stephan Martin; Aloys Berg Journal: Nutrients Date: 2022-07-30 Impact factor: 6.706